COVID-19
Conditions
Keywords
Coronavirus
Brief summary
This is a single-arm open label trial for hospitalized patients with COVID-19 (Coronavirus). The primary endpoint of the study is to assess the requirement for mechanical ventilation in patients who are admitted to the hospital with COVID-19 infection and a Pulse Oxygen Level \</= 93% on room air. The primary endpoint analysis will be performed using all enrolled patients.
Detailed description
Patients with COVID-19 who are admitted with respiratory distress will be considered for enrollment on this study. Patients will be screened and then if they meet eligibility criteria will be enrolled. Abatacept will be administered on Day 1 at a dose of 10 mg/kg. Patients will then be followed closely through 90 days post-treatment.
Interventions
DRUGAbatacept
10mg/kg intravenously administered on Day 1
Sponsors
Boston Children's Hospital
Bristol-Myers Squibb
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must be at least 18 years old. * Confirmed SARS-CoV-2 infection, confirmed by polymerase chain reaction (PCR) \</=4 days prior to enrollment * Evidence of respiratory distress including SpO2 \</=93% on room air. * Radiographic evidence of pulmonary infiltrates. * Ability to understand and the willingness to provide informed consent.
Exclusion criteria
* Patients already intubated/mechanically ventilated at screening will not be eligible. * Patients with uncontrolled severe bacterial or fungal infections at the time of enrollment. * Patients with previously diagnosed autoimmune disorders or who were on immunosuppressive medications prior to developing COVID-19 are not eligible * Pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mechanical ventilation-free survival | 30 days | Cumulative incidence of mechanical ventilation-free survival at 30 days after initiation of abatacept |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Days until pulse oxygen is > 93% on room air | 30 days | Number of days until patient recovers with SpO2 \> 93% |
| Days until supplemental oxygen is no longer required | 30 days | No supplemental oxygen for at least 24 hours |
| Duration of fever >= 38°C | 30 days | Number of days until fever is less than 38°C |
| Overall survival | 90 days | Patient survival status through 90 days |
| Duration of days on a ventilator | 30 days | Number of days a patient is on a ventilator, if applicable |
| Secondary infections | 90 days | Number of Secondary infections in patients treated with abatacept |
| Change in Clinical Status, based on 7-point ordinal scale | 14 days | Change in clinical status from baseline, as assessed by a 7-point ordinal scale on Day 14 |
| Viral load | 28 days | Viral load at baseline and on Days 7, 14, 21, 28 (each +/- 2 days) after the first abatacept dose. |
| Radiographic Improvement | 14 days | Improvement in lung findings based on CXR (chest x-ray) |
| Infusion reactions | 14 days | Number of Infusion Reactions in patients treated with abatacept |
Countries
United States
Outcome results
None listed